CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17146522 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR [ MedDRA 19.1 LLT (10047571): Visual impairment ] 67 DA MO YR (Year) Female Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht der betroffenen Person: "Nach Mamma-Ca-OP (02-) Beginn der Einnahme von Tamoxifen ab Mai. Nach Katarakt-OP (beidseitig) im Sept. und keiner Verbesserung der Sehfähigkeit Diagnostizierung durch Kontrastmitteluntersuchung einer trockenen Makuladegeneration (links) und einer feuchten Makuladegeneration (rechts); deshalb Beginn einer Behandlung mit Lucentis ab vember. Keine Verbesserung der Sehkraft über den Zeitraum von 4 Wochen. Persönliche Entscheidung: Tamoxifen absetzen. Zeitraum 5 Wochen. Ab Kontrolluntersuchung Mitte Dezember und erneuter Injektion verbesserte Sehkraft. Im Januar 2017 erneute Einnahme Tamoxifen aus Angstgründen --> langsame Verschlechterung der Sehkraft ab 01/2017. Ausgleich durch Anpassung einer Sehhilfe (Brille). Zunächst Besserung durch die Brille. Anschliessend schleichende Verschlechterung der Sehkraft." 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 20 Mg milligram(s) every Day" [ 3360 Mg Oral milligram(s) { 20 Mg milligram(s), 1 in 1 Day } ] 17. INDICATION(S) FOR USE Breast carcinoma 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 06-MAY- III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) lucentis from NOV- 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? þ YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.1 (10074431): Cancer surgery ] from FEB- to FEB- Continuing: [ MedDRA 19.1 (10063797): Cataract operation ] from SEP- to SEP- Continuing: [ MedDRA 19.1 (10025409): Macular degeneration ] Continuing: Unknown 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17146522 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start End [MedDRA 19.1 PT (10047571): Visual impairment ] not recovered/not resolved 5 Month [ MedDRA 19.1 LLT (10047571): Visual impairment ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) 06-MAY- A: daily dose: 20 Mg milligram(s) every Day B: 3360Mg milligram(s) C: 20Mg milligram(s) D: 1 E: 1Day Oral Breast carcinoma Identification of the country where the drug was obtained Name of holder/applicant nicht spezifiziert Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event 4 Month Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? Yes * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Active drug substance name
Report Page: 3 of 5 Drugrecurrecnce (MedDRA version for reaction(s)/event(s) recurred) [ MedDRA 19.1 (10047571): Visual impairment ] 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) (... continuation...) Concomitant Drug and batch no. Start End Duration Dose * Route(s) of Administration Indication(s) lucentis NOV- A: B: C: D: E: Macular degeneration Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name ranibizumab 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start End Continuing Comments [ MedDRA 19.1 (10074431): Cancer surgery ] FEB- FEB- Mamma-Karzinom-OP [ MedDRA 19.1 (10063797): Cataract operation ] SEP- SEP- Katarakt-OP bds. [ MedDRA 19.1 (10025409): Macular degeneration ] Unknown trockene Makuladegeneration links [ MedDRA 19.1 (10067791): Wet macular degeneration ] Unknown feuchte Makuladegeneration rechts [ MedDRA 19.1 (10006198): Breast cancer recurrent ] Unknown
Report Page: 4 of 5 Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017016511 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20170426 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? DE-CADRBFARM-2017016511 Yes Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 97 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax
Report Page: 5 of 5 Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Elderly >65.Lj. Weight (kg) 79 Height (cm) 176 Last menstrual periode Text for relevant medical history and concurrent conditions